13:16:06 EDT Fri 03 May 2024
Enter Symbol
or Name
USA
CA



Cybin Inc
Symbol CYBN
Shares Issued 339,242,044
Close 2023-11-14 C$ 0.62
Market Cap C$ 210,330,067
Recent Sedar Documents

Cybin has cash of $18.1-million at Sept. 30

2023-11-14 19:32 ET - News Release

Mr. Doug Drysdale reports

CYBIN REPORTS SECOND QUARTER FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

Cybin Inc. today released its unaudited financial results for its second quarter ended Sept. 30, 2023, and recent business highlights.

"Advancing our clinical programs with the goal of changing the treatment landscape in mental health has always been Cybin's mission," said Doug Drysdale, chief executive officer of Cybin. "We have made enormous progress during the past quarter, with ample momentum to carry us through year-end and into 2024. We are actively gathering important data from CYB003, our deuterated psilocybin analogue program, and CYB004 and SPL028, our deuterated DMT programs, with top-line readouts expected before the end of 2023. As a company, we are proud of our consistent progress, robust patent portfolio, skilled and dedicated team of drug development experts, and believe we are well positioned to progress our pipeline toward potential regulatory approval."

Recent business and pipeline highlights

Announced closing of unit offering led by one of the company's largest institutional shareholders. The company has closed its previously announced underwritten offering. In connection with the offering, the company issued an aggregate of 66,666,667 units of the company at a price of 45 U.S. cents per unit for aggregate gross proceeds of $30-million (U.S.) ($41.5-million). Each unit comprised one common share in the capital of the company and one common share purchase warrant. Each warrant is exercisable to acquire one common share at a price of 51 U.S. cents per common share any time on or after the date that is six months after issuance until May 14, 2029, subject to acceleration in certain circumstances.

Announced unprecedented positive phase 2 interim data for CYB003, the company's proprietary deuterated psilocybin analogue, in major depressive disorder (MDD). The study met its primary efficacy endpoint and demonstrated a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12-milligram dose compared with placebo. At the three-week primary efficacy end point, the reduction in MDD symptoms, defined as change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, was superior in participants assigned to CYB003 compared with the participants who received placebo by 14.08 points (p equals 0.0005, Cohen's d equals 2.152). To date, CYB003 has demonstrated a favourable safety and tolerability profile at all doses evaluated, up to 16 mg.

Completed the acquisition of Small Pharma Inc. by way of a plan of arrangement under the Business Corporations Act (British Columbia), and pursuant to the terms of an arrangement agreement dated Aug. 28, 2023. Small Pharma is now a wholly owned subsidiary of Cybin. The combined N,N-dimethyltryptamine (DMT) and deuterated DMT (dDMT) programs creates the most advanced data set of systematic research on these short-duration psychedelic molecules. The development portfolios are highly complementary and provide multiple opportunities to create operational and cost synergies.

  • Reported positive top-line data from a phase 1b SPL026 (DMT)-SSRI drug interaction study in MDD, which showed positive safety, tolerability and efficacy data in respect of the interaction between selective serotonin reuptake inhibitors (SSRIs) and SPL026, native DMT in patients with MDD.
  • Positive results were also reported earlier in the year from the phase IIa trial investigating the safety, tolerability and efficacy of intravenous SPL026, with supportive therapy, in 34 patients with moderate/severe MDD. The trial met its key primary and secondary end points with SPL026 demonstrating a rapid and durable anti-depressant response to at least six months, as measured by MADRS. Further analyses of additional secondary and exploratory end points demonstrated clinically relevant improvements in self-reported depression, anxiety and well being. These data demonstrate proof of concept for dDMT and serve to further derisk this development program.

Strengthened patent portfolio with the addition of four new patents.

  1. The United States Patent and Trademark office granted U.S. patent No. 11,724,985, to a deuterated psilocybin analogue in the company's CYB003 investigational drug program. The patent, which is expected to provide exclusivity until 2041, includes composition of matter claims to deuterated tryptamines in support of the company's CYB003 and CYB004 clinical programs, as well as claims directed toward methods of treating MDD and treatment-resistant depression.
  2. United States patent No. 11,771,681 provides composition of matter protection for certain deuterated analogues of DMT.
  3. United States patent No. 11,773,062 provides protection for the medical use and the novel, efficient and scalable synthesis of certain analogues of DMT.
  4. The European Patent Office (the EP) granted a patent protecting Cybin's proprietary deuterated psilocybin analogue and DMT programs. This EP patent No. 4,031,529 provides composition of matter protection for certain deuterated tryptamine compounds, including deuterated psilocybin analogues within the CYB003 program and deuterated analogues of DMT within Cybin's DMT program, as well as their medical use.

Upcoming clinical milestones and future studies:

CYB003 -- deuterated psilocybin analogue program 1

  • Complete phase 2 top-line safety and efficacy data readout for CYB003 in MDD, including six-week data and results on the incremental benefit of a second dose expected in Q4 2023.
  • Submission of top-line data to U.S. Food and Drug Administration (FDA) following readout, for an end of phase 2 meeting in early 2024.
  • Additional phase 2 data assessing durability of effect for CYB003 at 12 weeks expected in Q1 2024.
  • Progression to an international, multisite phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population, with recruiting expected to begin around the end of Q1 2024.

dDMT program 1

  • Phase 1 dosing, pharmacokinetic and pharmacodynamic, and safety data for CYB004 and part A data for SPL028 expected around year-end 2023.
  • Initiate phase 2 proof-of-concept study in participants with generalized anxiety disorder in Q1 2024.
  • A CYB004 subcutaneous formulation study in Q1 2024 in addition to the SPL028 formulation work.

Second quarter financial information

  • Cash totalled $18.1-million as of Sept. 30, 2023.
  • With the recently completed offering of units and a combination of the company's current cash position, current at-the-market equity program and assuming exercise in full of the warrants issued as part of the units, the company has access to over $138-million.
  • Net loss was $11.9-million for the quarter ended Sept. 30, 2023, compared with a net loss of $10.0-million in the same period last year.
  • Cash-based operating expenses totalled $12.5-million for the quarter ended Sept. 30, 2023, compared with $11.3-million, in the prior-year quarter, of which $2.1-million and $2.0-million were one-time costs, respectively.
  • Cash flows used in operating activities were $11.5-million for the quarter ended Sept. 30, 2023, compared with $14.7-million in the same period last year, of which $2.1-million and $2.5-million were one-time, non-recurring costs and $2.4-million were recorded to prepaid expenses related to future clinical work.
  • Cash flows received from financing activities were $20.4-million for the quarter ended Sept. 30, 2023, compared with $4.6-million in the same period last year, related to the net proceeds on the issuance of common shares through the company's Aug. 3, 2023, financing and its at-the-market equity program.

About Cybin Inc.

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin's goal of revolutionizing mental health care is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The company is currently developing CYB003, a proprietary deuterated psilocybin analogue for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder, and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

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